Spinal construct with flexible member

ABSTRACT

A system for securing a flexible member to a vertebra includes a flexible member, a fixation member, and an inserter. The flexible member includes two ends. The fixation member includes a head and a shank that defines a longitudinal axis of the fixation member. The head defines a slot that passes through the head orthogonal to the longitudinal axis. The slot receives a portion of the flexible member. The inserter includes a handle and a tubular member that has proximal and distal end portion. The proximal end portion is attached to the handle and the distal end portion extends from the handle. The tubular member defines a passage between the proximal and distal end portions. The distal end portion includes a couple for receiving the head of the fixation member with the portion of the flexible member received in the slot of the flexible member.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of, and priority to, U.S.Provisional Patent Application Ser. No. 62/189,261, filed Jul. 7, 2015,the entire contents of which is hereby incorporated by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to spinal fixation constructs and, morespecifically, to spinal fixation constructs with a flexible member.

2. Discussion of Related Art

The spinal column is a complex system of bones and connective tissuesthat provide support for the human body and protection for the spinalcord and nerves. The adult spine is comprised of an upper and lowerportion. The upper portion contains twenty-four discrete bones, whichare subdivided into three areas including seven cervical vertebrae,twelve thoracic vertebrae and five lumbar vertebrae. The lower portionis comprised of the sacral and coccygeal bones. The cylindrical shapedbones, called vertebral bodies, progressively increase in size from theupper portion downwards to the lower portion.

An intervertebral disc along with two posterior facet joints cushion anddampen the various translational and rotational forces exerted upon thespinal column. The intervertebral disc is a spacer located between twovertebral bodies. The facets provide stability to the posterior portionof adjacent vertebrae. The spinal cord is housed in the canal of thevertebral bodies. It is protected posteriorly by the lamina. The laminais a curved surface with three main protrusions. Two transverseprocesses extend laterally from the lamina, while the spinous processextends caudally and posteriorly. The vertebral bodies and lamina areconnected by a bone bridge called the pedicle.

The spine is a flexible structure capable of a large range of motion.There are various disorders, diseases and types of injury, whichrestrict the range of motion of the spine or interfere with importantelements of the nervous system. The problems include, but are notlimited to, scoliosis, kyphosis, excessive lordosis, spondylolisthesis,slipped or ruptured discs, degenerative disc disease, vertebral bodyfracture, and tumors. Persons suffering from any of the above conditionstypically experience extreme or debilitating pain and often timesdiminished nerve function. These conditions and their treatments can befurther complicated if the patient is suffering from osteoporosis, orbone tissue thinning and loss of bone density.

Spinal fixation apparatuses are widely employed in surgical processesfor correcting spinal injuries and diseases. When the disc hasdegenerated to the point of requiring removal, there are a variety ofinterbody implants that are utilized to take the place of the disc.These include interbody spacers, metal cages and cadaver and human boneimplants. In order to facilitate stabilizing the spine and keeping theinterbody in position, other implants are commonly employed, such asbone screws and rods. Depending on the pathology and treatment, asurgeon will select the appropriate spinal rod material and size,specifically, the cross-sectional diameter.

One growing trend seen post-surgical treatment of a patient's spine isthe incidence of proximal junctional kyphosis (PJK), which is typicallyan adult spinal deformity surgical outcome if the lumbar lordosis andthoracic kyphosis are not properly restored post-surgery. PJK appears ator above the cranial-most thoracic level treated. Even though PJK mostcommonly occurs in the thoracic region of the spine, it can also occurin various spinal regions and may occur above or below the instrumentlevels and may impact the next adjacent level or two that is notinstrumented. This type of failure is called adjacent level failure.Symptoms of PJK and adjacent level failure include pain, neurologicaldeficit, ambulatory difficulty and poor maintenance of sagittal balance.For patients that present with these symptoms, often the only treatmentis an additional surgery. The incidence rate of PJK may be upward of 50%in long construct, instrumented fusion cases. Factors contributing tothis condition are the end vertebrae selection, facet violation,weakened structural support due to significant soft tissue disruption,extensive junctional paraspinal musculature dissection and loss ofintegrity of the posterior tension band.

One thought to address the problem of PJK, which is caused by theaccelerated degeneration of the joint capsules and smaller articularprocesses at one or two levels above or below the junctional region, isto decrease the structural rigidity of the construct at the top of theconstruct just below the proximal junction, thereby providing atransition from the relatively stiff instrumented spine to the moreflexible non-instrumented spine.

Spinal rods are typically made of cobalt chrome, stainless steel, ortitanium alloy. However in order to transition to a less stiff constructat the top, other less rigid materials may be employed to provide thedesired stiffness. A continuing need exists for an improved device, animproved system, and an improved method for performing spine surgerythat does not create additional morbidity post-surgical treatment.

SUMMARY

The present disclosure relates to a spinal construct including a rigidportion and a flexible portion. The flexible portion can be positionedin a cephalad direction and/or a caudal direction relative to the rigidportion. The flexible portion transitions a portion of a load from therigid portion of the spinal construct to the patient's anatomy to reducethe load on an uninstrumented vertebral level adjacent the rigidportion. It is envisioned that by reducing the load on theuninstrumented vertebral level adjacent the rigid portion of the spinalconstruct, instances of PJK can be reduced.

In an aspect of the present disclosure, a fixation member includes ahead and a shank. The shank defines a longitudinal axis of the fixationmember and the head defines a slot that passes through the headorthogonal to the longitudinal axis. The slot is configured to receive aflexible member.

In aspects, the head includes a retention bar that passes over the slot.The retention bar may be configured to receive a flexible memberthereabout.

In another aspect of the present disclosure, a system for securing aflexible member to a vertebra includes a flexible member, a fixationmember, and an inserter. The flexible member has two ends and a centralportion between the ends. The fixation member includes a head and ashank. The shank defines a longitudinal axis of the fixation member andthe head defines a slot that passes through the head orthogonal to thelongitudinal axis. The slot receives the central portion of the flexiblemember. The inserter includes a handle and a tubular member. The tubularmember has a proximal end portion that is attached to the handle and adistal end portion that extends from the handle. The tubular memberdefines a passage between the proximal and distal end portions. Thedistal end portion includes a coupler for receiving the head of thefixation member with the central portion of the flexible member receivedin the slot of the fixation member. The flexible member passes throughthe passage of the tubular member and into a groove defined in anoutside surface of the handle.

In aspects, when the head is received within the coupler, the shank ofthe fixation member is rotatably fixed to the inserter.

In some aspects, the handle includes a securement member that ispivotally coupled to the handle for selectively fixing the flexiblemember within the groove of the handle. The securement member may be alever that includes a grip. The securement member may have a securedposition in which the grips is adjacent the handle such that theflexible member is fixed within the groove and an unsecured position inwhich the grip is spaced apart from the handle such that the flexiblemember is slidable within the groove. In the secured position of thesecurement member, the grip may engage the flexible member.

In certain aspects, the groove extends from a proximal end of the handletowards a distal end of the handle. The ends of the flexible member mayextend into the grove from an opening defined in the proximal end of thehandle.

In another aspect of the present disclosure, a method of securing aflexible member to a bony element includes attaching the flexible memberto a head of a fixation member, rotatably fixing the head of thefixation member in a coupler of an inserter with the flexible memberattached to the head, fixing the flexible member within a groove of ahandle of the inserter to secure the fixation member to the inserter,engaging a bone element with a shank of the fixation member secured tothe inserter, and driving the fixation member into the bony element withthe inserter.

In aspects, attaching the flexible member to the head of the fixationmember includes passing an end of the flexible member through a slotdefined in the head of the fixation member. Fixing the flexible memberwithin the groove of the handle may include passing ends of the flexiblemember through the groove of the handle such that a central portion ofthe flexible members is disposed within the groove with a securementmember in an unsecured position and transitioning the securement memberto a secured position to fix the flexible member within the groove.Fixing the flexible member within the groove of the handle may includepassing ends of the flexible member through a passage of the tubularmember that is engaged with the head of the fixation member.Transitioning the securement member to the secured position may includepivoting the securement member such that a grip of the securement memberis pivoted towards the handle. Transitioning the securement member tothe secured position may include engaging the flexible member with thegrip of the securement member.

In some aspects, the method may include transitioning the securementmember to an unsecured position after driving the fixation member intothe bony element with the inserter to release the flexible member formthe groove of the handle. Transitioning the securement member to theunsecured position includes pivoting a grip of the securement memberaway from the handle.

In certain aspects, driving the fixation member into the bony elementwith the inserter includes rotating the inserter.

Further, to the extent consistent, any of the aspects described hereinmay be used in conjunction with any or all of the other aspectsdescribed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the present disclosure are described hereinbelow withreference to the drawings, which are incorporated in and constitute apart of this specification, wherein:

FIG. 1 is a perspective view of an exemplary fixation member provided inaccordance with the present disclosure;

FIG. 2 is a perspective view of an exemplary inserter provided inaccordance with the present disclosure;

FIG. 3 is a cross-sectional view taken along section line 3-3 of FIG. 2;

FIG. 4 is a perspective view of a system for securing a flexible memberto a bony element including the fixation member of FIG. 1 and theinserter of FIG. 2;

FIG. 5 is a perspective view of the system of FIG. 4 with the fixationmember secured to the inserter;

FIG. 6 is a cross-sectional view taken along section line 6-6 of FIG. 5;

FIG. 7 is a perspective view of the fixation member of FIG. 4 secured toa bony element with the flexible member attached to the fixation member;

FIG. 8 is a posterior view of a partial spinal column with a spinalconstruct attached in accordance with the present disclosure;

FIG. 9 is a side view of the partial spinal column of FIG. 8;

FIG. 10 is a posterior perspective view of the partial spinal column ofFIG. 8; and

FIG. 11 is an enlarged view of the indicated area of detail of FIG. 10.

DETAILED DESCRIPTION

Embodiments of the present disclosure are now described in detail withreference to the drawings in which like reference numerals designateidentical or corresponding elements in each of the several views. Ascommonly known, the term “clinician” refers to a doctor, a nurse or anyother care provider and may include support personnel. Additionally, theterm “proximal” refers to the portion of the device or component thereofthat is closer to the clinician and the term “distal” refers to theportion of the device or component thereof that is farther from theclinician. In addition, the term “cephalad” is known to indicate adirection toward a patient's head, whereas the term “caudal” indicates adirection toward the patient's feet. Further still, the term “lateral”is understood to indicate a direction toward a side of the body of thepatient, i.e., away from the middle of the body of the patient. The term“posterior” indicates a direction toward the patient's back, and theterm “anterior” indicates a direction toward the patient's front.Additionally, terms such as front, rear, upper, lower, top, bottom, andsimilar directional terms are used simply for convenience of descriptionand are not intended to limit the disclosure. In the followingdescription, well-known functions or constructions are not described indetail to avoid obscuring the present disclosure in unnecessary detail.

This disclosure relates generally to a spinal fixation constructincluding a flexible member for tethering a bony element to the spinalconstruct. The spinal construct includes a fixation member for securingthe flexible member to a bony element, an inserter for securing thefixation member in a bony element, and a rigid portion. The spinalconstruct limits movement in a kyphotic direction while permittingmovement in the opposite direction. In addition, a method for installingthe spinal construct on a spine of a patient is disclosed.

Referring now to FIG. 1, a fixation member 10 for tethering a flexiblemember 40 (FIG. 4) to a bony element is described in accordance with thepresent disclosure. The fixation member 10 includes a head 20 and ashank 30. As shown, the head 20 is hexagonal in shape; however, the head20 can have any shape suitable for engagement of the inserter 50 (FIG.2) as described in greater detail below. The head 20 includes aretention bar 22 that defines a slot 24 which passes through the head 20orthogonal to a longitudinal axis A-A of the fixation member 10 definedby the shank 30. The shank 30 is configured to secure the fixationmember 10 in a bony element. As shown, the shank 30 includes threads 32that threadably engage a bony element to fix the fixation member 10relative to the bony element. It is envisioned that the head 20 can bemoveable relative to the shank 30. For example, the head 20 can bepivotable and/or rotatable relative to the shank 30.

Referring now to FIGS. 2 and 3, an inserter 50 for securing the fixationmember 10 in a bony element with a flexible member 40 (FIG. 4) attachedto the fixation member 10 (FIG. 1) is described in accordance with thepresent disclosure. The inserter 50 includes a handle 60 and a tubularmember 70 extending from the handle 60. The tubular member 70 includes aproximal end portion 72 and a distal end portion 74. The tubular member70 defines an axis B-B and a passage 78 about the axis B-B between theproximal and distal end portions 72, 74. The proximal end portion 72 iscoupled to the handle 60. As shown, the proximal end portion 72 isthreadably coupled to a connector 62 of the handle 60; however, theproximal end portion 72 can be welded, adhered, or joined to the handle60 by a variety of known suitable methods.

The distal end portion 74 of the tubular member 70 defines a coupler 76for releasably engaging the head 20 (FIG. 1) of the fixation member 10.The coupler 76 is sized and dimensioned to receive the head 20 such thatthe head 20 is rotatably fixed to the tubular member 70. For example,when the head 20 is hexagonal in shape, as described above, the coupler76 may define a hexagonal opening such that each face of the head 20 isfully engaged with a wall defining the coupler 76. Alternatively, whenthe head 20 is hexagonal in shape, the coupler 76 may be a dodecagonalopening such that a portion of each face of the head 20 is engaged witha wall defining the coupler 76. It is contemplated that the connectionbetween the head 20 and the inserter 50 can be a friction fit, a pressfit, a snap fit, a snap into, a snap over, a clip in, a magnetic, orother known suitable means for releasably attaching two members.

The coupler 76 is in communication with the passage 78 such that theflexible member 40 (FIG. 4) can pass through the slot 24 of the head 20and the passage 78 of the tubular member 70 when the head 20 is receivedwithin the coupler 76.

The handle 60 defines a longitudinal groove 64 in an outer surfacethereof that receives the flexible member 40 as detailed below. Asshown, a proximal end 66 of the handle 60 defines an opening 65. Thegroove 64 is aligned with the opening 65 such that the flexible member40 can pass from the opening 65 into the groove 64 about the proximalend 66 as described in greater detail below.

With additional reference to FIG. 4, the handle 60 includes a securementmember 67 that selectively secures the flexible member 40 within thegroove 64. As shown, the securement member 67 is a lever that ispivotally coupled to the handle 60 and has a grip 68. The securementmember 67 is movable between a secured position (FIG. 2) in which thegrip 68 of the securement member 67 is adjacent or in contact with thehandle 60. In the secured position of the securement member 67, the grip68 is positioned within the groove 64 to secure the flexible member 40within the groove 64 and prevent the flexible member 40 from withdrawingthrough the passage 78 as detailed below. The securement member 67 alsohas an unsecured position (FIG. 4) in which the grip 68 of thesecurement member 67 is spaced apart from the handle 60 such that theflexible member 40 is moveable within the groove 64 and the passage 78.It is envisioned that the securement member 67 is biased towards thesecured position.

Additionally or alternatively, the handle 60 can include other means forpreventing the flexible member 40 from withdrawing through the passage78. For example, the handle 60 can include a clip or cleat (not shown)that is attached to the ends of the flexible member 40 to prevent theflexible member 40 from withdrawing through the passage 78. It iscontemplated that the handle 60 can include a capstan, cam cleat, or taband slot arrangement to secure the flexible member 40 within the groove64 and prevent the flexible member 40 from withdrawing through thepassage 78.

With reference to FIGS. 4-7, a method of securing the fixation member 10in a bony element with the inserter 50 is described in accordance withthe present disclosure. Initially referring to FIG. 4, the flexiblemember 40 is passed through the slot 24 (FIG. 1) of the fixation member10 to attach the flexible member 40 to the head 20 of the fixationmember 10. The flexible member 40 includes ends 42 and a center section44 therebetween. When the flexible member 40 is attached to the head 20,the center section 44 of the flexible member 40 is wrapped around theretention bar 22 of the head 20 (FIG. 1).

Continuing to refer to FIG. 4, with the flexible member 40 secured tothe head 20, the ends 42 of the flexible member 40 are passed throughthe passage 78 of the tubular member 70, out the opening 65, and intothe groove 64 of the handle 60 with the securement member 67 in theunsecured position. With the securement member 67 in the unsecuredposition, the ends 42 of the flexible member 40 can slide within thegroove 64 and under the securement member 67. The ends 42 of theflexible member 40 are drawn through until the head 20 of the fixationmember 10 is within the coupler 76 of the tubular member 70 as shown inFIGS. 5 and 6. With the head 20 within the coupler 76 of the tubularmember 70, the ends 42 of the flexible member 40 are drawn until theflexible member 40 is taut from the head 20, through the passage 78, andwithin the groove 64.

With the flexible member 40 drawn taut, the securement member 67 ispivoted to the secured position as shown in FIG. 5. When the securementmember 67 is pivoted to the secured position, the grip 68 of thesecurement member 67 engages the flexible member 40 to secure theflexible member 40 within the groove 64 as shown in FIG. 6. When theflexible member 40 is secured within the groove 64, the flexible member40 is fixed relative to the handle 60 and prevented from withdrawingthrough the passage 78 of the tubular member 70. It will be appreciatedthat when the flexible member 40 is taut and fixed relative to thehandle 60, the head 20 of the fixation member 10 is secured within thecoupler 76 of the inserter 50.

With continuing reference to FIGS. 5 and 6, with the head 20 of thefixation member 10 secured in the coupler 76 of the inserter 50, theinserter 50 is used to secure the fixation member 10 into a bonyelement. Specifically, the inserter 50 is positioned such that the shank30 of the fixation member 10 engages a bony element. With the shank 30engaging the bony element, the inserter 50 is rotated to affect rotationof the shank 30 such that the shank 30 is threaded into the bonyelement. It is contemplated that a pilot hole can be drilled in the bonyelement to assist in threading the shank 30 into the bony element.

When a desired length of the shank 30 is threaded into the bony element,the inserter 50 is withdrawn from over the head 20 of the fixationmember 10 as shown in FIG. 7. It will be appreciated that the securementmember 67 may be pivoted towards the unsecured configuration to permitthe flexible member 40 to slide from within the groove 64 of the handle60 and through the passage 78 of the tubular member 70.

With the fixation member 10 secured to a bony element and inserter 50withdrawn such that the flexible member 40 free from within the passage78, the flexible member 40 is attached to a spinal construct to limitmovement of the bony element relative to another bony element asdetailed below.

With reference to FIGS. 8-11, the flexible member 40 is attached to arigid portion of a spinal construct 100 that is secured to vertebrae ina thoracic portion of the spine. Specifically, the spinal construct 100includes two spinal rods 110, 112 that are secured on either side of aspinous process of vertebrae T7 and T8 by pedicle screws 120. As shown,each of the pedicle screws 120 includes a head 122 and a shank 126 (FIG.11). The shank 126 of each pedicle screw 120 is secured in a respectivevertebra. The head 122 defines a saddle 124 that receives the one of thespinal rods 110, 112 to secure a respective one of the spinal rods 110,112 to the head 122. As shown, the head 122 is a taper-lock style headto secure the respective spinal rod 110, 112 within the saddle 124. Itis contemplated that other known means for securing the respectivespinal rod 110, 112 within the saddle 124 may also be used including,but not limited to, a set screw (not shown) threadably engaged with thesaddle 124.

The spinal construct 100 also includes a cross-connector 130 thatinterconnects the spinal rods 110, 112. The cross-connector 130 includessaddles 132 that secure the cross-connector 130 to the spinal rods 110,112. The cross-connector 130 also includes retainers 134 positionedbetween the saddles 132. Each of the retainers 134 define a retentionslot 136 and includes a retention screw 138.

For detail descriptions of exemplary pedicle screws reference can bemade to U.S. Pat. No. 8,403,971, filed Apr. 23, 2010, and U.S. Pat. No.8,814,919, filed Apr. 23, 2010. For detailed descriptions of exemplarycross-connectors reference can be made to U.S. Pat. No. 8,961,565, filedAug. 23, 2010. For detailed description of exemplary retainers referencecan be made to U.S. Provisional Patent Application No. 62/152,325, filedApr. 24, 2015, entitled “Tethering Screw System.” The entire contents ofeach of these disclosures are incorporated by reference.

Alternatively, it is envisioned that the flexible member 40 may besecured about a bony element. The ends 42 of the flexible member 40 maypass through a clamp (not shown) before being secured to thecross-connector 130. For detailed descriptions of exemplary clamps,reference can be made to U.S. Patent Publication No. 2014/0257397, filedMar. 11, 2014, the entire disclosure of which is incorporated byreference.

With particular reference to FIG. 11, each of the flexible members 40 issecured to a respective retainer 134 of the cross-connector 130 that ison the same side of the spinous process as the fixation member 10associated with the flexible member 40. The ends 42 of the flexiblemember 40 are passed through the retention slot 136 of the respectiveretainer 134 such that the central portion 44 of the flexible member 40forms a loop between the retainer 134 and the head 20 of the fixationmember 10. The size of the loop can be adjusted to allow a desiredamount of kyphotic movement while preventing excessive kyphodic movementbetween the spinal construct 100 and the vertebra engaged by thefixation member 10. After the size of the loop is adjusted, theretention screw 138 is used to secure the central portion 44 of theflexible member 40 in the retainer 134 which fixes the size of the loop.It will be appreciated that as the vertebrae (e.g., T6 and T7) moverelative to one another, the central portion 44 of the flexible member40 slides through the slot 24 of the head 20 to limit the movement ofthe vertebrae relative to one another.

The flexible member 40 may be composed of a single material or be acombination of materials. The flexible member 40 is construed from oneor more biocompatible materials including, but not limited to,polyethylene, ultra high molecular weight polyethylene (UHMWPE),polypropylene, polyetherimide, poly sulfone, polyacetal, nylon,poly-ether-ether-ketone (PEEK), polytetraflouroethylene, or combinationsthereof. For example, it is envisioned that the flexible member 40 mayinclude a core with a sheath disposed about the core. It is contemplatedthat the flexible member may be braid in various shapes including, butnot limited to, a round braid or a flat braid. For detail descriptionsof exemplary flexible members and uses thereof reference can be made toU.S. patent application Ser. No. 14/644,428, filed Mar. 11, 2015, theentire contents of which are incorporated by reference.

As detailed above, the spinal construct 100 is attached to the thoracicportion of a spinal column; however, it is envisioned that the spinalconstruct can be attach anywhere along the spinal column with thefixation members 10 and flexible members 40 attached to a vertebraadjacent to or spaced apart from the rigid portion of the spinalconstruct 100 in a cephalad direction and/or a caudal direction.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Any combination ofthe above embodiments is also envisioned and is within the scope of theappended claims. Therefore, the above description should not beconstrued as limiting, but merely as exemplifications of particularembodiments. Those skilled in the art will envision other modificationswithin the scope of the claims appended hereto.

What is claimed:
 1. A fixation member comprising: a head and a shank,the shank defining a longitudinal axis of the fixation member, the headdefining a slot passing through the head orthogonal to the longitudinalaxis, the slot configured to receive a flexible member.
 2. The fixationmember according to claim 1, wherein the head includes a retention barthat passes over the slot, the retention bar configured receive aflexible member thereabout.
 3. A system for securing a flexible memberto a vertebra, the system comprising: a flexible member having a twoends and a central portion between the ends; a fixation member includinga head and a shank, the shank defining a longitudinal axis of thefixation member, the head defining a slot passing through the headorthogonal to the longitudinal axis, the slot receiving the centralportion of the flexible member; and an inserter including a handle and atubular member, the tubular member having a proximal end portionattached to the handle and a distal end portion extending from thehandle, the tubular member defining a passage between the proximal anddistal end portions, the distal end portion including a coupler forreceiving the head of the fixation member with the central portion ofthe flexible member received in the slot of the fixation member, theflexible member passing through the passage of the tubular member andinto a groove defined in an outside surface of the handle.
 4. The systemaccording to claim 3, wherein when the head is received within thecoupler, the shank of the fixation member is rotatably fixed to theinserter.
 5. The system according to claim 3, wherein the handleincludes a securement member pivotally coupled to the handle forselectively fixing the flexible member within the groove of the handle.6. The system according to claim 5, wherein the securement member is alever including a grip, the securement member having a secured positionin which the grip is adjacent the handle such that the flexible memberis fixed within the groove and an unsecured position in which the gripis spaced apart from the handle such that the flexible member isslidable within the groove.
 7. The system according to claim 6, whereinin the secured position of the securement member the grip engages theflexible member.
 8. The system according to claim 3, wherein the grooveextends from a proximal end of the handle towards a distal end of thehandle, the ends of the flexible member extending into the groove froman opening defined in the proximal end of the handle.
 9. A method ofsecuring a flexible member to a bony element, the method comprising:attaching the flexible member to a head of a fixation member; rotatablyfixing the head of the fixation member in a coupler of an inserter withthe flexible member attached to the head; fixing the flexible memberwithin a groove of a handle of the inserter to secure the fixationmember to the inserter; engaging a bony element with a shank of thefixation member with the fixation member secured to the inserter; anddriving the fixation member into the bony element with the inserter. 10.The method according to claim 9, wherein attaching the flexible memberto the head of the fixation member includes passing an end of theflexible member through a slot defined in the head of the fixationmember.
 11. The method according to claim 9, wherein fixing the flexiblemember within the groove of the handle includes: passing ends of theflexible member through the groove of the handle such that a centralportion of the flexible member is disposed within the groove with asecurement member in an unsecured position; and transitioning thesecurement member to a secured position to fix the flexible memberwithin the groove.
 12. The method according to claim 11, wherein fixingthe flexible member within the groove of the handle further includespassing ends of the flexible member through a passage of a tubularmember engaged with the head of the fixation member.
 13. The methodaccording to claim 11, wherein transitioning the securement member tothe secured position includes pivoting the securement member such that agrip of the securement member is pivoted towards the handle.
 14. Themethod according to claim 13, wherein transitioning the securementmember to the secured position includes engaging the flexible memberwith the grip of the securement member.
 15. The method according toclaim 9, further comprising transitioning a securement member to anunsecured position after driving the fixation member into the bonyelement with the inserter to release the flexible member from the grooveof the handle.
 16. The method according to claim 15, whereintransitioning the securement member to the unsecured position includespivoting a grip of the securement member away from the handle.
 17. Themethod according to claim 9, wherein driving the fixation member intothe bony element with the inserter includes rotating the inserter.